Kornimate/medical-research-clean huggingface dataset:
use of a multimedia presentation for informed consent

Conditions: Improving Informed Consent Process

Summary: this is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. the goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process.

background: informed consent (ic) is an ethical process for ensuring patient autonomy. multimedia presentations (mmp) often aid the ic process for research studies. thus, it follows that mmp would improve ic in clinical settings. objective: to determine if mmp for the ic process for ketamine sedation improves parental satisfaction and comprehension as compared to standard practice. design/methods: this two phase study compared two methods of ic for ketamine sedation of pediatric patients. phase one was a randomized, prospective study that compared the standard verbal consent to a mmp. phase two implemented the mmp into daily work flow. parents completed a survey evaluating their satisfaction of the ic process and assessing their knowledge of ketamine sedation. primary outcome measures were parental overall satisfaction with the ic process and knowledge of ketamine sedation.

Eligibility criteria:
inclusion criteria: * receiving ketamine sedation for fracture reduction * less than 18 years of age * english as primary language exclusion criteria: * patients who received medications in addition to ketamine for sedation * families where english was not the primary language

Keywords: informed consent ethics
non-invasive measurement of central hemodynamics by electrical impedance tomography

Conditions: Comparison of Availability for Prediction of Volume Responsiveness; Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation

Summary: the purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.

the purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.

Eligibility criteria:
inclusion criteria: * age \>18 years * indication for advanced invasive hemodynamic monitoring due to operative procedure * necessity of postoperative invasive ventilation exclusion criteria: * age \<18 years * known affections cardiac function * presence of cardiac arrhythmias * contraindication for placement of central venous or femoral artery catheter

Keywords: hemodynamic monitoring volume responsiveness electrical impedance tomography
effect of human amniotic epithelial cells on children with spastic cerebral palsy

Conditions: Spastic Cerebral Palsy

Summary: this study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (haec) transplant in the management of children with spastic cerebral palsy.

cerebral palsy is one of the most common congenital (existing at or before birth) disorders of childhood.spastic cerebral palsy causes stiffness and movement difficulties.there is no cure for the disease now. this study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (haec) transplant in the management of children with spastic cerebral palsy. haec will be intrathecal transplanted. functional status is determined by gross motor function measure-66 and fine motor function measure. spasticity is evaluated by using modified ashworth scale(mas).

Eligibility criteria:
inclusion criteria: * signed informed consent document; * gross motor function classification system (gmfcs) levels iii-v; * parents accepted voluntarily cell therapy for their children and followed-up. exclusion criteria: * have a history of severe allergic; * serological tests such as aids, hepatitis b, syphilis, etc; * hereditary metabolic diseases of nervous system; * tumor or hematological diseases.
poststroke depression in hemorrhagic stroke

Conditions: Stroke Hemorrhagic; Depression

Summary: a double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (asah), a type of stroke.

patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.

Eligibility criteria:
inclusion criteria: patients 18-85 years of age aged 18 years and older will be included. patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included. only patients who provide informed consent will be included. exclusion criteria: non-english speaking patients will be excluded. patients currently receiving therapy for depression or related mental health diagnoses before admission will be excluded. patients with medical contraindications to fluoxetine therapy will be excluded. pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded. patients with active psychosis will be excluded. patients who are incarcerated or in police custody will be excluded. patients with a comorbidity or cognitive impairment (as determined by a recruiter-administered montreal cognitive assessment; patients scoring \>26 are considered of appropriate cognitive function for consent) that precludes informed consent and participation in the research interviews will be excluded.

Keywords: stroke hemorrhagic stroke subarachnoid hemorrhage depression
promote follow-up observational study

Conditions: Heart Failure

Summary: the purpose of the study is: * to evaluate the heart failure risk status (hfrs) feature performance. * to establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of hfrs feature as supplemental information.


Eligibility criteria:
inclusion criteria: patients that meet all of following criteria could be included in the study: * implant of a commercially available medtronic crtd or icd device with or without the optivol fluid status monitoring feature. * inclusion in the medtronic carelink network. * local consent available for cl network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered. exclusion criteria: * patients under the age of 18 years.
intervention to preserve beta-cell function in gad ab-positive diabetes

Conditions: GAD Ab Positive Clinically Type 2 Diabetic Patients

Summary: we tested the hypothesis that insulin therapy rather than sulfonylurea (su) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (spiddm) or latent autoimmune diabetes in adult (lada).

in a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (gadab). sixty gadab-positive non-insulin requiring diabetic patients with duration of diabetes =/\<5 years were assigned to either the su group (n = 30) or the insulin group (n = 30). serum c-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. the primary endpoint was insulin-dependency (iddm: integrated c-peptide values \[sigma c-peptide\] \<4 ng/ml).

Eligibility criteria:
inclusion criteria: * subjects should use su agents to obtain as a goal good glycemic control. * duration of diabetes within 5 years from the onset (or diagnosis). exclusion criteria: * subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded. * subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.

Keywords: spiddm lada gad antibody beta cell function insulin
functional electrostimulation on the upper lip in multiple sclerosis

Conditions: Electrode Site Reaction; Therapy; Directly Observed Therapy

Summary: multiple sclerosis (ms) is an autoimmune disease where immune cells attack the body, triggering an inflammatory response. a study comparing multifield fes and conventional fes on upper extremity motor skills and functional independence in ms patients will be conducted. results suggest that both types of fes treatments normalize muscle tone, showing superior results compared to those without fes therapy. the study aims to compare the effects of both types on ms patients.

multiple sclerosis (ms) is an autoimmune disease in which cells of the immune system attack the body itself. this condition generates an activation of the immune system that triggers an inflammatory response. general objective: to compare the effect of multifield fes and conventional fes on upper extremity motor skills and functional independence in people with ms. methodology: a three-arm prospective longitudinal multicenter randomized controlled trial (rct) will be conducted: conventional therapy (control group, cg), an experimental group 1 (eg1) which in addition to this same treatment will use the conventional fes tool, through the globus elite device, and an experimental group 2 (eg2) which will differ from ge1 in that it will use the fes multi-field device through fesia grasp. results: it is expected that people who have used any type of fes will have a more normalized muscle tone compared to those who have not received this type of treatment. the research compares the effects of two types of fes in people with multiple sclerosis, focusing on improved motor skills and functional independence. both fes treatments are expected to normalize muscle tone, showing superior results compared to those who do not receive this therapy.

Eligibility criteria:
inclusion criteria: * be of legal age and sign the informed consent form. * not suffer from any pathology in the upper limb such as tendinitis, oedema, fractures, etc. * intact skin (no breaks, scratches, cuts, and other superficial or deep injuries) on the arm where the devices will be placed if applicable exclusion criteria: * severe medical problems. * use of a pacemaker. * pregnancy. * cutaneous neuropathies. * presence of other neuromuscular pathologies.

Keywords: fesia grasp multiple sclerosis multicampe therapy
validation of a quantra supported hemotherapy algorithm in cardiac surgery

Conditions: Hemorrhage; Bleeding

Summary: the aim of this study is to develop a coagulation algorithm based on quantra poct for the treatment of coagulopathic cardiac surgery patients.

in order to perform a targeted coagulation therapy during intra- and postoperative care of cardiosurgical patients, it is necessary to know the hemostatic potential. after blood samples have been taken for coagulation diagnosis, they are usually sent to the central laboratory. after analysis and validation, the results are transmitted electronically. the loss of time due to sample transport, analysis and provision of the results prolongs the time required to derive therapeutic measures. in recent years, point of care testing (poct) devices for the diagnosis of coagulopathic patients have become increasingly important. in our clinic, poct devices have been routinely used for intra- and postoperative targeted coagulation therapy for years. these include the rotem delta and multiplate. for analysis, a whole blood sample is pipetted together with test reagents. depending on the selected reagent, different parts of the coagulation cascade can be evaluated and, depending on this, an appropriate therapy can be derived. a coagulation algorithm developed in our clinic is based on these measurement results and has been used successfully for years for perioperative coagulation management. this algorithm requires additional information on the platelet function, which is also carried out as standard on the bed side using multi-plate analysis as poct. a new system for whole blood analysis has recently become available on the market. the quantra from hemosonics also allows the analysis of a whole blood sample on the bed side. due to the cassette structure, the time-consuming and potentially error-prone pipetting of a whole blood sample is no longer necessary. the aim of this study is to develop a coagulation algorithm based on quantra poct for the treatment of coagulopathic cardiac surgery patients.

Eligibility criteria:
inclusion criteria: \>18 years elective operation with cardiac bypass exclusion criteria: participation on another study

Keywords: cardiac surgery bleeding point of care testing poct algorithm based therapy
quality improvement in infection control and sepsis management in model regions

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: the german quality network sepsis is an association trying to improve quality of care for patients with sepsis, severe sepsis and septic shock or being in risc thereof. the icosmos trial investigates the impact on the use of routine data, a risk adjustment algorithm and feedback to all hospitals as well as a structured implementation for regular screening for deteriorating patients, and education on in-hospital mortality.

all german hospitals provide a set of routine data to federal adminsitration for reimbursement. this dataset includes all icd-10-codes (german adaption) as well as all procedure codes. this dataset is pseudonomized and risk adjusted for every individual case and afterwards feedbacked to each participating hospital including all accumulated data from all other hospitals as well as the german average for sepsis mortalities provided by the german federal institute of statistcs for benchmarkings. based on this data, the icosmos trial will provide support to all participating hospitals for two major strategies to be implemented 1. an algorithm for structured analysis of 1. low-risk-fatalities as potentially preventable deaths for underlying problems in diagnosis, treatment, etc 2. high-risk-survivors as "best practice" 3. coding errors for improvement of coding quality 2. a structured sreening program of every patient on every ward in every shift for deterioration and support algorithms including consiliary support and outreach teams as well as structured education the icosmos trial will investigate the effects as well on quality of coding and sepsis incidence as well as on sepsis-related sepsis in-hospital mortality for participating hospitals in comparison to the german average.

Eligibility criteria:
inclusion criteria for hospitals: * hospitals willing to participate inclusion criteria for patients / patients' data * age over 16 * coding of sepsis, severe sepsis, septic shock exclusion criteria for hospitals: * no intensive care unit on site

Keywords: quality improvement routine data risk adjustment sepsis, severe sepsis, septic shock quality of coding
a study to evaluate the safety, tolerability and pharmacokinetic properties of 9mw3811 in healthy subjects

Conditions: Pulmonary Fibrosis; Tumor

Summary: this is a first-in-human, single ascending dose study of 9mw3811, the primary objective of which is to evaluate the safety and tolerability of 9mw3811 in healthy adult participants.

the single ascending dose study will comprise 4 dose cohorts of 8 healthy participants each. in each cohort, participants will be randomized to receive 9mw3811 or placebo by 6:2.

Eligibility criteria:
inclusion criteria: 1. male or female participants between 18 and 55 years of age, inclusive. 2. male body weight ≥50.0 kg, or female body weight ≥45.0 kg, and body mass index (bmi) between 18.0 and 30.0 kg/m2, inclusive. 3. in good health determined by the investigator based on a medical evaluation, including a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ecg, laboratory evaluations. exclusion criteria: 1. clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities. 2. having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment. 3. use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the pi or designee) 4. participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study 5. participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening 6. participants with one or more clinically significant positive test results of hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody or human immunodeficiency virus (hiv) antibody 7. history of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (morphine, methamphetamine, tetrahydrocannabinol acid, cocaine) 8. participants with a positive sars-cov-2 test prior to admission (polymerase chain reaction (pcr) and/or rapid antigen testing (rat), per site policy and pi discretion)
a family dyad-focused diabetes self-management intervention for african american adults

Conditions: Diabetes Mellitus, Type 2

Summary: a family dyad-focused diabetes self-management for african american adults with type 2 diabetes is a randomized controlled trial (rct) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin a1c) and health-related quality of life (hrqol) in african american adults with type 2 diabetes (t2d).

eligible participants and their family members will be randomly assigned to either the intervention and control group. patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. all participants will be assessed at baseline, post-intervention and six months after intervention.

Eligibility criteria:
inclusion criteria: individual with type 2 diabetes: * self-identification as african american; * 40 years or older * type 2 diabetes diagnosis for at least six months; * a1c \> 7.0% at time of enrollment; * being able to speak and read english; * being able to walk; * having an adult family member/close friend willing to co-participate in the study. family members: * adults (18 years or older, with or without t2d); * residing in the same household as the t2d participants; * being a spouse, adult child or sibling; or close friend * being able to walk; * being able to speak and read english. exclusion criteria: individual with t2d and family members: * being pregnant or have an advanced or terminal condition; * being cognitively impaired or unable to provide informed consent; * lack conclusive evidence of t2d for patients with t2d.
effects of preoperative gabapentin versus pregabalin on shoulder pain after laparoscopic cholecystectomy

Conditions: Pain, Postoperative; Cholecystectomy, Laparoscopic

Summary: the aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.

preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. the incidence of postoperative nausea and vomiting appears to be decreased. the other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic surgery.

Eligibility criteria:
inclusion criteria: * uncomplicated laparoscopic cholecystectomy * american society of anesthesiologists (asa) status \< 3 exclusion criteria: * acute cholecystitis * conversion to open cholecystectomy * history of epilepsia, psychiatric disorders and cognitive impairment * pregnancy and breastfeeding * allergy to pregabalin and/or gabapentin * chronic pain * chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory drugs

Keywords: pregabalin gabapentin post operative pain laparoscopic cholecystectomy
telerehabilitation in severe acquired brain injury

Conditions: Brain Injuries; Stroke

Summary: we will investigate the use of tr, based on advanced information and communication technology (ict) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counselling and vital parameters monitoring. the aim of the study is to evaluate that tr is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments (utrt), taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs. the enrolled patients will be balanced for pathology and randomized in two groups, performing tr (g1) or standard rehabilitation training (g2), respectively, according to a pc-generated random assignment.tr will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and qol. in both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about one hour a day, five days/week, for 12 weeks. two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, one week after the beginning and at the end of the tr.


Eligibility criteria:
inclusion criteria:age range 18 to 65 years; diagnosis of sabi; availability at home internet connection. exclusion criteria: severe cognitive and behavioral impairments, cardio-respiratory instability or other medical illness potentially interfering with the treatment, severe limb spasticity, high-risk of spontaneous fracture, substance abuse.

Keywords: telerehabilitation motor outcomes cognitive dysfunction